Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA.
On this page:
- Medical Device Reports Associated with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- How Do I Report a Problem about Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines to the FDA?
- Questions about Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines?
Related FDA pages
- Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- Recommendations for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
- FDA Activities Related to Recalled Philips Ventilators, BiPAP Machines, and CPAP Machine
- Foam Testing Summary for Recalled Philips Ventilators, BiPAP Machines, and CPAP Machine
Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam breakdown. Eight of those reports were from the U.S. There were no reports of patient injury or death among those 30 MDRs. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or "806 report") in June 2021.
Since April 2021, the FDA has received more than 109,000 MDRs, including 426 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.
|Dates||MDRs Received||Reports of Deaths in MDRs|
|April 1, 2021 - April 30, 2022||>21,000||124*|
|May 1, 2022 - July 31, 2022||>48,000||48*|
|August 1, 2022 - October 31, 2022||>21,000||99*|
|November 1, 2022 - December 31, 2022||>8,000||79*|
|January 1, 2023 - March 31, 2023||>6,000||44*|
|April 1, 2023 – June 30, 2023||>4,000||32|
*The number of deaths has been updated to reflect Philips' retrospective review of MDRs.
A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients.
Although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.
If you have any problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
For more information on Philips’ recall notification, contact your local Philips representative or visit Philips' medical device recall information page.
More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.
If you have additional questions, contact the FDA’s Division of Industry and Consumer Education (DICE).